INTRODUCTIONS OF BOARD MEMBERS AND GUESTS

The meeting opened with brief introductions of Board Members and guests. Five new members of the Board were welcomed: Carol Espy-Wilson, E.E., Ph.D., University of Maryland; David Good, M.D., Penn State Milton S. Hershey Medical Center; Marilyn Hamilton, StimDesigns, LLC; S.B. Lee, M.D., M.P.H., Johns Hopkins University; and, Gary Smith. M.D., Dr.P.H., Ohio State University.

ANALYSIS OF REHABILITATION RESEARCH SUPPORT ACROSS THE NIH

In response to a previous Board discussion, Dr. Ralph Nitkin presented some data (gathered by Dr. Theresa Cruz) on the NCMRR’s role in promoting rehabilitation research across the NIH. Analyzing NIH grants for fiscal year 2009, Dr. Cruz did a keyword search for those grants that had particular relevance for medical rehabilitation and verified their connection by reading through the title, abstract, and specific aims. Not surprisingly, there was major support from (in rank order) the NCMRR in the NICHD, as well as the National Institute of Neurological Diseases and Stroke, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Deafness and Other Communication Disorders, the National Eye Institute, the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the National Institute of Diabetes and Digestive and Kidney Disorders, and another 11 NIH Institutes with more modest connections.

The NIH also prepares reports for Congress on specific diseases, conditions, and research areas in more than 200 categories, including a “rehabilitation” category. These reports are prepared at the end of each fiscal year using a sophisticated computerized process in which grants are assigned to specific Research, Condition, Disease Categories (RCDC), which are defined based on key-word searches and weighting factors, to yield an informational fingerprint of each topic. Although the official NIH fingerprint for “rehabilitation” comes out to $404 million for fiscal year 2009, this computerized definition includes research on drug, alcohol, and mental health rehabilitation, and thus may over-estimate the true level of “medical rehabilitation” research funded at the NIH. The more detailed but unofficial figure of $280 million provided by Dr. Cruz maybe a more accurate estimate of the type of rehabilitation supported by the NCMRR. Thus, NCMRR support of almost $77 million in fiscal year 2009 was leveraged almost four-fold across the NIH, including support from the NIH Office of the Director. Looking longitudinally, RCDC analysis suggested that support for rehabilitation research has risen steadily in recent years, commensurate with the increases in the total NIH appropriation. RCDC analysis also indicated that the most prominent rehabilitation research topics were stroke, assistive technologies, spinal cord injury (SCI), and traumatic brain injury (TBI), respectively.

Beyond the levels of research funding, Dr. Nitkin noted that the NCMRR also takes an active role in various trans-NIH activities, including Rehabilitation Working Group, Neural Prosthetics, TBI, the Pain Consortium, Neuroscience Blueprint, Multi-scale Modeling, and Medical Technologies and Robotics. The NCMRR is also involved in collaborations with the Department of Veterans Affairs (VA), the Department of Defense, the National Science Foundation (NSF), the National Institute on Disability and Rehabilitation Research (NIDRR), the Centers for Disease Control and Prevention (CDC), the Agency for Health Care Research and Quality, the Center for Medicare and Medicaid Service, and the Food and Drug Administration.

A motion was made that the NABMRR affirm its mandate to review and assess federal research priorities, activities, and funding regarding medical rehabilitation research, and to advise the Directors of the NCMRR and the NICHD on a research plan. The motion also acknowledged limited resources and committed to discussing opportunities to go forward in meeting the mandate. The Board discussed the need to revisit the Research Plan for the NCMRR, which was first published in 1993 (available online at http://www.nichd.nih.gov/publications/pubs/upload/plan.pdf (PDF - 223 KB)).

Although the original legislative statute for the NCMRR provided a role to coordinate rehabilitation research activities among federal agencies, it was pointed out that the primacy of this role may conflict with the legislative mandate of other governmental agencies. For example, the NIDRR was made the statutory chair of the Interagency Committee on Disability Research. Moreover, given limited resources, overlapping mandates, and contrasting operating procedures, members questioned whether a singular locus of leadership was realistic or practical across these diverse agencies. The Board discussed how the definition of disability varies across agencies, and noted that this definition influences the assessment tools and outcome measures used. The Board questioned whether it should attempt to promote a more universal concept of disability. There was discussion that, given the overlapping mandates, perhaps a more practical strategy would be for the NIH to continue to support investigator-initiated efforts and promote collaborative activities whenever possible. Ultimately, the motion was put to a vote, and it passed by a vote of nine for, and four against, with three abstentions. Board members agreed to review the Research Plan for the NCMRR and discuss strategies for updating or supplementing the document.

HOME-BASED TECHNOLOGIES IN SUPPORT OF INDEPENDENT LIVING

Dr. Mary Rodgers, University of Maryland, discussed a recent NIH workshop on home-based technologies to support independent living that she helped to organize as part of her sabbatical with the NIBIB. The impetus for this workshop came from the need to support an aging population, increasing life expectancy, home management of chronic disease, and advocacy for continued independence. The workshop attracted more than 60 researchers and advocates and spanned five federal agencies, including representatives from several NIH Institutes. The workshop highlighted some interesting technologies that can support and monitor home-based activities for people with physical as well as cognitive disabilities; activities included health support, risks for and causes of falls, and mental supports, but some approaches still needed more real-world testing and validation. A major theme that emerged was the need to involve users in research and development to increase the likelihood that technologies will be adopted, as well as the need for systemic and integrated approaches that, when appropriate, connect to clinical outcomes.

Potential users generally appreciated the trade-off that the possible intrusion of these technologies in their home would provide extended support for independent living. Some of home-based technologies also raised potential privacy issues. Subjects would generally allow concerned family members or even clinicians to monitor their activities, but were more wary of providing access to government and insurers. Some of these approaches may have applications in hospital or nursing-home settings.

SPECIAL DELIVERY: PREGNANCY IN WOMEN WITH PHYSICAL DISABILITIES

Dr. Caroline Signore, NICHD Pregnancy and Perinatology Branch, reviewed a recent NIH workshop that focused on maternity and parenting support for women with physical disabilities. Generally, women with disabilities are treated as “small, sheltered, sexless individuals;” but increasing numbers of women with SCI, multiple sclerosis, and other disabling conditions are seeking to have children. Although this situation may present increased risks to mother and baby, there is remarkably little research or clinical guidelines on how to support these women, nor is there information to help them overcome potential barriers involved with prenatal care and parenting.

The workshop reviewed the physiological changes associated with a normal pregnancy as well as possible risks associated with altered ambulation and transfers, skin ulceration, balance and falls, embolisms, and increased stress. The workshop also discussed two other issues: possible risks to the developing fetus resulting from medications that the mother may need to take, and evidence suggesting an increased incidence of preterm birth and fetal growth impairment in this population. Dr. Signore also explained that, during labor, the mother may also be at risk for autonomic dysreflexia, but this risk could be treated/prevented with epidural anesthesia. Support for mothers with disabilities would also require physical modifications to examining tables and delivery suites. In conclusion, there are specific clinical issues that need to be pursued, and environmental modifications and attitudinal barriers to be overcome.

Drs. Susanne Seagrave, Sheila Lambowitz, and Susan Miller of the CMS sought the Board’s feedback on a new initiative to support studies of inpatient rehabilitation that address provisions in the Patient Protection and Affordable Care Act. Section 304 of the Act requires CMS to collect data from facilities, but the legislation is not explicit on what information is to be collected, nor on the quality measures used. Thus, the CMS is seeking advice from the research community on measures to be used in inpatient settings, rehabilitation-relevant outcome measures, and any other advice on evaluating the delivery of service in these domains. CMS was also tasked with developing a list of conditions or complications to be treated in post-acute care settings and was seeking advice on sources of evidence-based practice and policies.

INTERNATIONAL ASSESSMENT OF TECHNOLOGIES FOR PERSONS WITH DISABILITIES

Drs. Ted Conway, NSF, and Mary Rodgers discussed their recent work with the World Technology Evaluation Center (WTEC), which is partially supported by the NSF, NIH, and the VA. Drs, Conway and Rodgers were part of an impressive team of rehabilitation researchers and engineers that WTEC sent to European labs to compare notes on the latest trends in robotics, rehabilitation technologies, sensory devices, and functional electrical stimulation. The final workshop report, delivered in November 16, 2010, can be viewed at http://www.tvworldwide.com/events/nsf/disability/101116/ and will also be published in the Journal of Neurorehabilitation. The WTEC group was particularly impressed with advances in combinational therapies, personalized musculoskeletal modeling, gait training, neck and should pain treatments, behavioral and cognitive assessment, wearable sensor technology, knee prostheses, and robotics.

REPORT OF THE NCMRR DIRECTOR

Dr. Michael Weinrich, director of the NCMRR, started with an update of activities at the federal level. Within the NIH, the National Institute on Alcohol Abuse and Alcoholism and the National Institute for Drug Abuse, as well as other relevant programs across the NIH, would be merged into a new Institute on addiction research. In addition, the NIH was proposing a new National Center for Advancing Translational Sciences, which would subsume parts of the National Center for Research Resources. The NIDRR designated former Board member Sue Swenson as acting director, in addition to her current role as Deputy Assistant Secretary of the Office of Special Education and Rehabilitative Services in the Department of Education.

Dr. Weinrich noted a small dropoff in NCMRR funding, partially due to the completion of the TBI Clinical Trials Network and to limited approval for new research initiatives in the current year. Paylines across the NIH have become even more competitive, but program staff continued to seek support and collaboration from other NIH Institutes whenever possible. NCMRR staff actively participated in the Interagency Committee on Disability Research, the NIH Rehabilitation Coordinating Committee, and activities with the Department of Defense (especially the Defense Advanced Research Projects Agency). NCMRR staff also participated in a number of professional meetings and workshops.

PLANNING FOR NCMRR 20TH ANNIVERSARY CELEBRATION IN MAY, 2011

Dr. Michael Weinrich led a brief discussion of possible ways to celebrate the 20th anniversary of the formation of the NCMRR, which comes up in 2011. He noted that it would also be an opportunity to highlight rehabilitation research in general. The Board discussed the possibility of a day-long symposium that initially reviewed the formation of the NCMRR as a rehabilitation research focus in the NIH, and then highlighted research advances and future opportunities. This symposium could be coordinated with the next Board meeting in May or December 2011.

USE OF PROGRAM ANNOUNCEMENTS (PA) TO PROMOTE REHABILITATION RESEARCH

NCMRR staff led a discussion of the use of PAs to promote research in a specific domain. PAs are sponsored by an NIH Institute(s) to highlight specific research interests. But unlike Requests for Applications (RFAs), PAs do not have set-aside funds and generally do not get preferential funding. Thus, responsive applications must compete with the larger pool of investigator-initiated proposals for funding. Nonetheless, PAs stimulate researcher applications in most cases; staff expressed some frustration that rewards for these efforts were limited given the tight paylines across the NIH.

Peer-review scores largely drive funding decisions, but is was unclear whether peer reviewers read the background PA documents provided to them, or whether they give any special consideration to applications developed in response to PA initiatives. The Board raised the possibility of further highlighting PAs to the review panels, but NIH review groups are charged with reviewing the science without regard to program priorities, meaning it was unlikely that the Center for Scientific Review would intervene. Another possibility would be for the NICHD and other institutes to reserve a small amount of funds for PA-responsive applications that get meritorious scores approaching the rigorous paylines. Because PAs seem to generate some response within the research community, the Board encouraged NCMRR staff to continue with the judicial use of these research solicitations and encouraged the NICHD to provide support for meritorious PA applications when appropriate.

REPORT OF NICHD DEPUTY DIRECTOR

Dr. Yvonne Maddox, Deputy Director of the NICHD, provided updates on support for research at the NIH. With tight budgets, she noted a need for continued collaborations with other Institutes and agencies. She indicated that the NIH was currently under a continuing resolution, which could be extended well into the fiscal year. In fiscal year 2010, the NIH appropriation was $31.6 billion, which included $1.3 billion for the NICHD. These figures included supplemental funds from American Recovery and Reinvestment Act (ARRA), which amounted to $327 million for the NICHD and $20 million specifically to the NCMRR. The NCMRR used ARRA funds to support additional research on wound healing, cell regeneration, pharmacological treatments, promoting movement, enhancing exercise, and assistive technologies.

Given budgetary constraints across the NIH, the NICHD payline was being set at the 11th percentile with 15 precent administrative reductions. The Institute was also exploring the possibility of a select pay strategy to provide some flexibility for funding a few additional innovative studies just beyond the payline. The NICHD was also reevaluating support for training and career development activities, starting with review of T32 departmental training grants. One consideration was to provide a centralized review of NICHD T32 applications with appropriate expertise, rather than have the applications dispersed in their respective review committees by subject matter. Also under consideration were questions about the criteria for a successful training program. Dr. Maddox indicated that the NCMRR gets strong training support, with nearly one-quarter of the NICHD T32 grants.

The Board asked Dr. Maddox for advice on fulfilling its mandate to provide recommendations to the NICHD and the NIH in general. Dr. Maddox encouraged the Board to provide input into the white papers coming from the NICHD Scientific Vision process and to send representatives to meet with the NICHD Director. The Board also discussed strategies to promote rehabilitation across the NIH as well as other federal agencies. Dr. Maddox assured the Board that the NCMRR has good working relationships with other rehabilitation relevant programs across the NIH.

PROMOTING HEALTH, ACTIVITY, AND DIET FOR CHILDREN WITH DISABILITIES

Drs. Ralph Nitkin and Michael Marge reviewed a recent NIH workshop designed to develop an evidence base to support health promotion through physical activity and diet in children with physical disabilities. The workshop was sponsored by the NIH Division of Nutrition Research Coordination (DNRC), which includes representatives from eight NIH Institutes and Centers, and the CDC. The NCMRR was seeking additional input from the Board on this topic in terms of potential research opportunities and strategies to support children with disabilities.

Despite the national focus on reducing overweight and obesity in children, children with disabilities are often excluded from these programs due to limited knowledge about effects of increased physical activity, special dietary needs, and physical and attitudinal barriers. Activity is particular important for children with disabilities to improve function and fitness, reduce secondary conditions, and promote health; it is equally important to combat obesity, which further exacerbates physical demands, and to promote participation and other psychosocial benefits. There might also be unique opportunities to support children with disabilities by working with parents, caretakers, and the environment.

The DNRC activities culminated in a workshop June 5, 2010, that included 16 outside experts and 15 federal staff. Participants briefly reviewed physical activity guidelines, nutritional guidelines, and outcome measures for children with disabilities and saw a demonstration of a community-based project to promote increased physical activity, good nutritional behaviors, and lifestyle changes. Discussion also included: secondary conditions and co-morbidities; family and psychosocial issues; strategies to define the “active ingredient” in exercise programs; difficulties of working across all disabilities (e.g., physical, behavioral, cognitive); diet, nutrition, and metabolism; extending clinical results to natural environments; and physical and community barriers to exercise.

Several possible research issues emerged from the workshop, including:

Behavioral and psychosocial studies to better understand the needs, motivations, sustainability, and barriers for children with disabilities and for their caregivers;

Development of outcome measures and standards, sensitive to their developmental stage, functional limitations, goals, and resources, for specific populations of children with disabilities;

Contraindications and limits of exercise for children with disabilities;

Environmental supports and barriers;

Interventional studies in exercise and diet to identify the active ingredient(s), understand environmental dynamics, optimize delivery, and validate efficacy in community and real-world settings; and

Unique challenges and opportunities to promote activity and diet in children with disabilities from specific racial/ethnic populations.

The Board made several constructive additions to the discussion of promoting the health of children with disabilities. Members noted that health status depends on the context of the disability, resources, and expectations, and that self-report measures often lack validity. Many of the issues discussed would also apply to promoting health in adults with disabilities. Motivation was a key issue, and efforts should focus on building life-long habits with goals that are meaningful to the individual. The Board pointed out that other federal initiatives on obesity lacked any focus on children with disabilities and even excluded them from any guidelines.

SUMMARY OF PREVIOUS DISCUSSIONS AND NEW BUSINESS

The Board was anxious to review the white papers that would result from the NICHD Vision process and suggested that specific Board members be assigned to review each of the documents and report back to the larger group.